Providing natural plant-derived products for psychedelic research seems like an obvious service, but a host of functional challenges including consistency, stability and degradation of these materials, typically prevent it from being a viable option. As a result, psychedelic research is normally conducted with synthetic or isolated compounds.
Filament, a Burnaby, British Columbia-based natural drug development company, is uniquely poised to buck that trend.
“Just telling people your drug is going to be natural is going to make their head spin,” says Ben Lightburn, CEO and co-founder of Filament.
“There are few botanical drugs–period–in the world,” he adds. “The only reason we’re alive for this opportunity is our extensive prior history making botanical drugs.”
On July 19, 2023, Filament announced its merger with Jupiter Acquisition Corporation, a special purpose acquisition corporation. The merger will give Filament an equity value of $176 million USD, representing 85-cents per Filament share, and a pro forma value of $210 million. The combined company will be listed on the Nasdaq.
However, Filament’s story begins with a different acquisition, that of Mazza Innovation, a Vancouver-based company that specialized in botanical extracts for a variety of markets, including medicine, cosmetics and food. That company was sold in 2018, but its core team wanted to continue working together on something that mattered, says Lightburn. Given the mental health application of psychedelics, it was easy to find the motivation to focus on that.
“We’ve all been touched by somebody suffering from a mental health condition or challenge,” he says. “It’s not everyday you have a botanical extract that can potentially help people cure their depression or PTSD.”
Meeting Pharmaceutical Standards
About a year after the sale of Mazza, Filament was formed. Their prior experience in botanicals gave them the knowledge of the “boring stuff,” says Lightburn—such as the higher manufacturing standards required for pharmaceutical grade products, as well as providing botanicals with consistent potency that remains stable in a compound and does not quickly degrade.
While Filament can’t patent the resulting products because they are based on freely cultivated plants, the company does protect their botanical extracts with manufacturing trade secrets, says Lightburn.
“What are the actual strains? What are the growing conditions? As you can imagine, those kinds of things can have a large impact on the final composition of the drugs. We never really disclose that.”
The result is a botanical drug containing the secondary compounds of the plant, rather than an isolated drug, says Lightburn. “We don’t really believe in isolation from natural,” he says. “If we were to isolate, who’s to say it would be different from a synthetic?”
One of their first projects to gain attention was an FDA approved natural extract of psilocybin. “The first and only, as far as we’re aware,” says Lightburn.
“Since then, we’ve had many other researchers, both academic and commercial players, reach out to us,” he says. “Most people didn’t think it was possible to have a natural psychedelic drug in clinic development. That’s blossomed into 15 or 20 other trials that are currently underway.”
Filament’s business model is a mixture of developing the drugs and licensing them to other players. “We license our drug candidates to other commercial entities that do drug development,” he says. “They pay us milestones; they pay us a royalty when their drug gets approved.”
Filament also licenses its drugs for low or no cost to some philanthropic and research causes as a way of giving back to the research community, says Lightburn. “We think it rises the tide for all boats,” he says.
It was Filament’s manufacture of natural psilocybin particularly that stood out to Negev Capital, a psychedelic medical intervention investment fund that has invested $1M USD in Filament.
“Botanical drugs are difficult to develop,” says Ken Belotsky, one of the founding partners of Negev Capital. “Any batch that you do should be consistent. That is very difficult to achieve in natural mushrooms. Filament did that.”
Belotsky praises Filament’s business model, but he also notes their compelling facility and what he says is a strong management team.
“We always look at the team,” he says. “Most of the team members worked together in the previous company. Some people work together so much they don’t want to work together again. But the management team, the employees, they know each other very well and work together very well.”
About a year ago, Filament became one of the “most interesting companies” in Negev’s Fund One, which has invested a total of $32M USD in psychedelic research. Although the fund is currently closed, Negev has announced its intention to invest up to an additional C$2 million in Filament.
“We believe Filament will become a platform player in the field of psychedelics,” he says. “Filament has a bright future, and I believe they will achieve their target.”
Complying With the Nagoya Protocol
One of the recent initiatives that Filament is engaged in involves importing iboga root to manufacture natural ibogaine for research. Ibogaine, which is derived from the iboga root, is relatively less studied than psilocybin, in part due to being harder to source. Iboga root primary grows in Gabon, a country on the western coast of Africa and Filament is going straight to the source.
To obtain iboga, Filament is partnering with Terragnosis, an iboga and ibogaine extraction company, and has the authorization of the Gabonese government. Lightburn says he is proud that Filament’s iboga root is compliant with the Nagoya Protocol, an international agreement for benefit sharing and compliance governing those who provide and use genetic resources. “Not a lot of companies do that,” he says.
“Many psychedelics come from Indigenous traditions and Indigenous communities around the world,” he adds. “We’re big believers in having a proper framework to have both proper informed consent from Indigenous communities, as well as a mechanism for reciprocity.”
For Filament, this means making sure the villages where the iboga is sourced, as well as the stewards who care for the roots, share in the results of the company’s efforts—both the initial sale and of the profits to come.
“In addition to the money that comes from buying the roots, there’s a percentage of any resulting products that we make and sell, as well as a percentage of any clinical services that are sold,” says Lightburn. “It’s like raw materials plus a percentage of revenues.”
The first shipment of iboga is enough to make sure the Filament facilities can process the root; later shipments will focus on improving the product, says Lightburn.
The Ayahuasca Pill
Concerns about Filament complying with the Nagoya Protocol were raised when the company began working with the botanical components of ayahuasca. The ayahuasca tea is made with the shrub Psychotria viridis and a vine known as Banisteriopsis caapi.
In an interview with Benzinga last December, Lightburn said that the Filament team had developed a medical grade ayahuasca pill and planned to enter it into a clinical trial at the University of California San Francisco. The company said it was trying to get FDA approval to begin a Phase 1 clinical trial within the first half of 2023.
Questions have been raised about how the company is obtaining consent from Indigenous people for their use of the plants used in ayahuasca and how they would share benefits with these communities as required under the Nagoya Protocol.
Lightburn said last year that Filament was working with only Nagoya-protocol compliant sources for their importation of raw plant materials that comprise a traditional ayahuasca brew. He told Benzinga that the company hopes one day to provide a standardized ayahuasca pill for use by people at retreat centers, but says the company is not trying to create a substitute for ayahuasca ceremonies or Indigenous cultural and spiritual traditions.
“We do think, and I think logically it does make sense, that the participants have a standardized product where they and the person administering it can know that it’s a consistent dose of the DMT,” Lightburn told Benzinga. “I think that could lead to better outcomes for everybody.”
Botanical Stability and Potency
Ibogaine may prove tricky for Filament to scale, says Sam Sabrin, advisor to venture capital funds JLS and Tabula Rasa. That’s in part because ibogaine is a bit “promiscuous” in the way it interacts with the brain.
“You want to be as targeted as possible to the receptors in the brain. You want that stability, selectivity and potency. Any off target effects usually result in side effects. In the case of ibogaine, the receptors that it tends to bind to are multiple,” he says.
“All those things are kind of challenges in terms of commercialization,” he adds. “Filament, with their background in manufacturing, is hoping to level their skillset there.”
If Filament is successful in manufacturing a stable botanical extract of iboga, the next question is what kind of IP or manufacturing trade secret the company can secure to anchor their place in the market and help attract investors, says Sabrin. He says that if Filament’s natural ibogaine is safe, commercially secure and exceeds the existing standards of care, it could be clinically successful.
“The proof is in the clinical data,” says Sabrin. “At the end of the day, you’re dealing with disease.”
“A couple of years ago, there were no clinical studies looking at natural drugs,” says Lightburn. “Many, many of the new studies that are getting launched are coming to us for drugs.”
In addition to the 15 or 20 clinical trials that are approved or underway investigating therapies with botanical compounds, there are about 50 or 60 that are in agreement, he says.
“All that has come in the last year or 18 months,” he adds.
Featured photo courtesy of Filament Health
UPDATE: This article was updated on July 20 to include information about Filament Health’s merger with Jupiter Acquisition Corporation.